RASAGILINE MESYLATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Rasagiline Mesylate (UNII: LH8C2JI290) (Rasagiline - UNII:003N66TS6T)

Available from:

Alvogen, Inc.

INN (International Name):

Rasagiline Mesylate

Composition:

Rasagiline 0.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Rasagiline mesylate tablets are indicated for the treatment of Parkinson’s disease (PD). Rasagiline is contraindicated for use with meperidine, tramadol, methadone, propoxyphene and MAO inhibitors (MAOIs), including other selective MAO-B inhibitors, because of risk of serotonin syndrome [See Warnings and Precautions (5.2)]. At least 14 days should elapse between discontinuation of rasagiline and initiation of treatment with these medications. Rasagiline is contraindicated for use with St. John’s wort and with cyclobenzaprine. Rasagiline is contraindicated for use with dextromethorphan because of risk of episode of psychosis or bizarre behavior. Pregnancy Category C There are no adequate and well-controlled studies of rasagiline in pregnant women. Rasagiline should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In a combined mating/fertility and embryo-fetal development study in pregnant rats, no effect on embryo-fetal development was observed at oral doses

Product summary:

Rasagiline Mesylate Tablets 0.5 mg: White to off-white, round, flat, beveled tablets, debossed with “R1” on one side and plain on the other side. Supplied as bottles of 30 tablets (NDC 47781-138-30) Rasagiline Mesylate Tablets 1 mg: White to off-white, round, flat, beveled tablets, debossed with “R2” on one side and plain on the other side. Supplied as bottles of 30 tablets (NDC 47781-139-30). Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

RASAGILINE MESYLATE- RASAGILINE MESYLATE TABLET
ALVOGEN, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RASAGILINE MESYLATE TABLETS SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RASAGILINE
MESYLATE TABLETS.
RASAGILINE MESYLATE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2006
INDICATIONS AND USAGE
Rasagiline mesylate tablets, a monoamine oxidase (MAO)-B inhibitor
(MAOI), is indicated for the treatment of Parkinson’s
disease (1)
DOSAGE AND ADMINISTRATION
Monotherapy: Rasagiline mesylate tablets 1 mg once daily (2.1)
As adjunct without levodopa: Rasagiline mesylate tablets 1 mg once
daily (2.1)
As adjunct to levodopa: Rasagiline mesylate tablets 0.5 mg once daily.
Increase dose to 1 mg daily as needed for
sufficient clinical response (2.1)
Patients taking ciprofloxacin or other CYP1A2 inhibitors: Rasagiline
mesylate tablets 0.5 mg once daily (2.2, 5.4)
Patients with mild hepatic impairment: Rasagiline mesylate tablets 0.5
mg once daily. Rasagiline mesylate tablets should
not be used in patients with moderate or severe hepatic impairment
(2.3, 5.5)
DOSAGE FORMS AND STRENGTHS
Rasagiline mesylate tablets 0.5 mg (containing, as the active
ingredient, rasagiline mesylate equivalent to 0.5 mg of
rasagiline base) (3)
Rasagiline mesylate tablets 1 mg (containing, as the active
ingredient, rasagiline mesylate equivalent to 1 mg of
rasagiline base) (3)
CONTRAINDICATIONS
Concomitant use of meperidine, tramadol, methadone, propoxyphene
dextromethorphan, St. John’s wort,
cyclobenzaprine, or another (selective or non-selective) MAO inhibitor
(4)
WARNINGS AND PRECAUTIONS
May cause hypertension (including severe hypertensive syndromes) at
recommended doses (5.1)
May cause serotonin syndrome when used with antidepressants (5.2)
May cause falling asleep during activities of daily living, daytime
drowsiness, and somnolence (5.3)
May cause hypotension, especially orthostatic (5.6)
May cause or exacerbate dyskinesia. Decreasing the levodopa dose